The world’s first biopharma built on blockchain technology has arrived. “We’ve created a new generation of pharmaceutical company, focused on dispersed product development through the use of today’s technology,” says Dr. Matthew Lee, Caywon Pharmaceutical Group’s VP of Innovations.
Analytical instrument can provide a high level of confidence in the integrity and quality of the manufactured product through scientific data, and that confidence can only be achieved through proper instrument qualification
According to the latest PharmSource Trend Report, "Bio/Pharma CapEx Trends 2016", biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility.
It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
Chromatography has always played a crucial role in the purification of biologics. It has constantly evolved, and methods and capabilities have improved to reflect the industry requirements. This article gives an overview of how experience, innovation, and dialogue with customers led to the development of a platform that has revolutionized the economics of large-scale chromatography column packing.
This application note describes a case study where live influenza virus was purified using single-use ReadyToProcess technology.
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
In cell culture-based vaccine production, scale-up of adherent cells is challenging. This study shows a process for scaling up adherent Vero cells from static cell factories to influenza production at 50 L scale using WAVE Bioreactor™ systems and ReadyToProcess single-use equipment.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
The consequences of inaccurate demand forecasting can be reputational damage, market share loss, lost days of production, destruction of inventory, and layoffs.
The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.